This is a two-phase study. Phase 1 will evaluate obesity-related behavioral and biological characteristics as potential predictors of response to behavioral treatment (BT) for weight loss. Phase 2 is a double-blind, placebo-controlled, RCT to test whether adding weight loss medication to BT improves 24-week weight loss, as compared to BT with placebo, in subjects identified as having suboptimal early weight loss after 4 weeks of individual behavioral weight control. All participants, regardless of their early weight loss, will receive the same BT program of diet, physical activity, and behavior therapy for weight loss for an additional 24 weeks (28 total weeks of treatment).
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Phase 1: Percent Weight Loss
Timeframe: Week -4 (start of BT run-in) to week 0 (randomization)
Phase 1: Number of Participants Who Are Categorized as Early Non-responders at Randomization (Week 0), Based on Percent Weight Loss
Timeframe: Week -4 (start of BT run-in) to week 0 (randomization)
Phase 1: Baseline Satiety, as Measured by Visual Analogue Scales (Range 0-100 mm) During a Test Meal; Satiety Quotient = [(Post-preload Rating - Fasting Rating Before Preload)] / (Energy Content of Preload in kcal) x 100.
Timeframe: Baseline (week -5)
Phase 1: Baseline Postprandial Change in GLP-1 During a Test Meal
Timeframe: Baseline
Phase 1: Baseline Gastric Emptying During a Test Meal (Acetaminophen Test)
Timeframe: Baseline
Phase 2: Percent Weight Loss
Timeframe: Week 0 (randomization) to week 24